Impulse News

First Optimizer® Smart Device Implanted in China

Mount Laurel, NJ, November 1, 2019 – On October 29, 2019, the first Optimizer Smart Cardiac Contractility Modulation CCMTM device was implanted in China at the Boao Super Hospital. Impulse Dynamics’ Optimizer Smart is one of the world’s most advanced heart failure treatment devices,  which now expands treatment options for patients with chronic heart failure through the special […]

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Impulse Dynamics receives MDSAP Certification from DEKRA Certification B.V.

ORANGEBURG, NY, September 24, 2019 – Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, has received the MDSAP Certification.  Following successful audits, DEKRA Certification B.V., issued the certificates on Monday, September 23rd. The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that […]

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Impulse Dynamics announces appointment of Gerald M. Haines as Executive Vice President and Chief Financial Officer

ORANGEBURG, NY, July 8, 2019 – Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, announced today the appointment of Gerald M. Haines to the position of Executive Vice President and Chief Financial Officer. Mr. Haines brings to Impulse Dynamics a wealth of experience and proven track record in business, corporate finance and […]

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Impulse Dynamics announces successful implantation of first patient since FDA approval of Optimizer® Smart System

ORANGEBURG, NY, May 8, 2019 – Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, announced today that the first patient to receive the Optimizer Smart System since the device was approved by the U.S. Food and Drug Administration was successfully implanted. The procedure, which occurred on Monday, May 6, at […]

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Impulse Dynamics receives FDA approval for breakthrough Optimizer® Smart System delivering CCM™ therapy for treatment of heart failure

Orangeburg, New York, March 21, 2019 – Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, announced today that it has received approval from the United States Food and Drug Administration for its first-in-class Optimizer Smart System. Designed to address a significant unmet medical need in heart failure, the Optimizer Smart System received Breakthrough Device […]

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FDA Panel Votes in Favor of the Optimizer® System

Orangeburg, New York, December 5, 2018 –Impulse Dynamics announces that the Circulatory System Devices Panel of the Medical Devices Advisory Committee of the U.S. Food and Drug Administration (FDA) voted in favor of the Optimizer® System for patients with moderate to severe systolic heart failure. Cardiac Contractility Modulation is the name of a therapy that […]

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First Patient Enrolled in International CCM™ Clinical Study for Heart Failure with Preserved Ejection Fraction at Karolinska University Hospital

Stuttgart, Germany, October 22nd 2018 – The first patient was enrolled in Impulse Dynamics’ international multi-center clinical trial testing the efficacy and safety of its CCM™ technology in heart failure patients with preserved Ejection Fraction (CCM™-HFpEF).  Cardiac contractility modulation is an established device based therapy shown in several international multicenter randomized controlled trials to be […]

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Clinical Registry Data and recently published FIX-HF-5C were presented at the Late-Breaking Clinical Trial Session at EHF 2018

Stuttgart, Germany, May 28th, 2018 – Impulse Dynamics Germany, GmbH announced results on “Real World” experience from its European Clinical Registry. The results were presented today by Prof. Gerd Hasenfuß, MD, Professor of Internal Medicine and Director of the Heart Center, University Hospital Göttingen, Germany at the Late-Breaking Clinical Trials Session of the European Heart […]

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FIX-HF-5C Late-Breaking Clinical Trial Data Presented at HRS 2018 with Simultaneous Publication in the JACC: Heart Failure

Orangeburg, New York, May 10, 2018 – Impulse Dynamics (USA), Inc. announced results from its FIX-HF-5C randomized, Controlled Trial of Cardiac Contractility Modulation in Heart Failure. The study results were presented by Prof. William Abraham, MD, Professor of Internal Medicine and Director, Division of Cardiovascular Medicine, The Ohio State University Wexner Medical Center, at the […]

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